RA Specialist
The success of a company depends on the passionate people we partner with.
Together, let's share our talents.
As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.
We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.
Indeed, Our “Together, Beyond Animal Health” vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.
As part of our “Diversity, Equity and Inclusion” policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.
Your missions :
Description
1. 负责与注册团队一起制定项目注册策略; 识别注册风险，组织风险评估，制定解决方案。
Responsible for working with the registration team to formulate project registration strategy, identify registration risks, organize risk assessment and develop solutions.
2. 负责与注册团队一起制定并优化适用于一个中国研发的注册管理制度及流程。
Responsible for working with the registration team to formulate and optimize the registration management system and process applicable to a Chinese I&D.
3. 负责捕捉、反馈、更新、解读行业发展以及法律法规政策信息，建立公司产品注册相关技术信息库，协助完成新产品立项有关的调研、评估工作。
Responsible for capturing, feeding back, updating and interpreting the industry development, laws, regulations and policies, establishing the technical information database related to the company's product registration, and assisting in the investigation and evaluation related to the project establishment of new products.
4. 编制注册工作计划、总结；根据注册法规要求，参与所负责项目开发技术路线的制定、审核；
Prepare the registration plan and summary; Participate in the define and review of the technical develop route for projects according to the regulations;
5. 撰写、整理申报材料（包括注册、变更注册、产品批准文号、新兽药监测报告等），提交申请并跟进审批进度，组织开展问题分析并制定最优解决方案
Write and submit dossier（including variation registration, product license application and new veterinary drug monitoring report.,etc） and follow up the approval progress, organize problem analysis and develop optimal solutions
Your profile :
Qualifications
1. 兽医学或生物学相关专业本科或同等学力(6年以上相关工作经历)；兽医学或生物学相关专业硕士及以上或同等学力(3年以上相关工作经历)。
Majors in veterinary medicine, biology-or project development related background. Bachelor degree or equivalent level with minimum 6 years’ experience, master or equivalent level with minimum 3 years’ experience.
2. 具备参与过至少一个项目的新兽药注册申报全过程的经验。
Participated in the whole process of new veterinary drug registration application for at least one project.
3. 熟悉中国兽药注册、GMP、GCP、转基因生物安全等相关法律法规。
Good knowledge of new veterinary drug registration, GMP, GCP, GMO and other relevant laws and regulations in China；
4. 能够识别注册风险，制定注册策略；在发现风险后能及时采取纠正措施。
Ability to identify registration risks and develop the registration strategy and take corrective measures in time after discovering risks.
5. 具备项目协调能力，能及时跟进推动注册申报进度。
Ability to coordinate registration projects, to follow up and promote the registration application progress in time.
6. 良好的申报资料撰写能力,能够独立撰写符合注册要求的报告。
Good write skills of the registration dossier. Ability to independently write registration dossiers that complies with the registration requirements.
7. 良好的沟通能力。能够在注册团队和项目开发团队之间进行垂直的沟通。
Good communication skills. Ability to deliver vertical back and forth communication between management.
8. 良好的英语听、说、读、写能力。
Good English listening, speaking, reading and writing skills.
